Today, the Supreme Court issued its opinion in Zubik v. Burwell. The per curiam opinion does not reach a decision on the merits of the case, in which religious employer petitioners argued that the Affordable Care Act’s contraceptive mandate substantially burdens the exercise of their religions in violation of the Religious Freedom Restoration Act. The Court remanded the consolidated cases, directing the Courts of Appeals to afford the parties “an opportunity to arrive at an approach going forward that accommodates petitioners’ religious exercise while at the same time ensuring that women covered by petitioners’ health plans ‘receive full and equal health coverage, including contraceptive coverage.'”

In a concurring opinion, Justice Sotomayor, joined by Justice Ginsburg, reminded lower courts that they should not construe the per curiam opinion or the Court’s earlier request for supplemental briefing as providing an indication of the Court’s views on the merits of this and related cases. Sotomayor noted that the Court has made similar disclaimers before, but”some lower courts have ignored those instructions.” She warned, “on remand in these cases, the Courts of Appeals should not make the same mistake.”

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The FDA announced a labeling change for the drug Mifeprex®, which, when used together with another drug called misoprostol, will terminate a pregnancy in the early stages. The labeling change will relax certain guidelines in prescribing practices and expand the time in which women can take this drug in order to induce an abortion. This change comes at a controversial time as the Supreme Court just heard oral arguments, and oddly asked parties for additional briefing, in a challenge to the contraception mandate under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). At the same time, anti-abortion candidates in the race to the White House have recently fueled the fire with inflammatory remarks while some pro-life proponents are framing the FDA’s change as a political move.

Labeling changes

While the FDA first approved Mifeprex in 2000, the latest announcement outlines a new approved regimen which was found to be safe and effective after a supplement application was submitted by the manufacturer. The FDA stated that the drug may be appropriately used to end a pregnancy through 70 days of gestation and through the following procedure:

The ingestion of 200g of Mifeprex on day one;

The ingestion of 800mcg of misoprostol 24 to 48 hours after taking the Mifeprex; and

A follow-up with a health care provider seven to 14 days after taking the Mifeprex.

The FDA also outlined an appropriate risk evaluation and mitigation strategy (REMS) for Mifeprex, as follows: (1) that it must be ordered, prescribed, and dispensed under the supervision of a health care provider with certain qualifications; (2) that those health care providers must complete a Prescriber Agreement Form before prescribing; (3) that it only may be dispensed in clinics, medical offices, and hospitals; and (4) the provider must obtain a Patient Agreement Form before dispensing it.

Effect

Other than extending the time in which this medication can be prescribed from seven weeks to 10 weeks, the new labeling reflects a change in dosage and procedure that, according to some sources, was adopted by physicians that prescribed Mifeprex off-label long ago. “The change brings the direction for taking the drug . . . in line with what has become standard medical practice in most states: reducing the dosage to 200 milligrams from 600 milligrams, decreasing the number of visits a woman must make to the doctor to two from three, and extending the period when she can take the pill to 10 weeks of pregnancy from seven weeks,” according to the New York Times. There is also evidence that fewer side effects accompany the lower dosage. The same article notes that while the new labeling might be applicable to all states at the moment, at least one state is already working to pass a law that would hold provider’s to the stricter standards imposed in the past.

Context

This FDA approval came at an interesting time for the abortion and contraceptive coverage controversy as, the day before this announcement, the Supreme Court issued an order asking for supplemental briefing in a case on which it had heard oral arguments the previous week and which challenged the contraception coverage mandate of the ACA. Some experts see this as the eight-Justice Court potentially looking for an avenue to strike a compromise on an issue and avoid a 4-4 vote, which would effectively result in the continuation of a circuit split and different laws applying in different jurisdictions on this issue. In this context, pro-life proponents argued that the FDA announcement is a politically fueled move to satisfy the “abortion industry” and pro-choice groups. Others defended it as unrelated to election year politics and as simply part of the FDA’s regulatory responsibility in the face of a supplement drug application.

Religious non-profits seeking an exemption from the Patient Protection and Affordable Care Act’s (ACA) (P.L. 111-148) mandate that employers pay for contraceptives as part of standard health insurance plans are gearing up for the March 23, 2016, hearing scheduled in front of the Supreme Court. In November, the Court consolidated seven cases challenging the birth-control mandate into one: Zubik v. Burwell. Unhappy religious organizations outside of the seven are not waiting for the Supreme Court’s decision to make their next move, they have already filed another petition before the Court.

In this, the fourth legal challenge of the law to be accepted by the Court since the ACA was passed in 2010, involves religious, non-profit corporations that morally object to the ACA provision that allows their employees to obtain contraceptive coverage through their health insurance, even if those contraceptive products are provided by insurance companies and the government, and not by the institutions. These organizations claim that this indirect participation is offensive and violates their rights to religious freedom. The federal government, however, believes that these institutions have numerous employees who may not necessarily share the beliefs of religious groups that sponsor the non-profits, and these workers would be harmed by the exclusions.

Grace Schools and Diocese of Ft. Wayne

Just in case the Supreme Court does not decide in favor of the religious organizations, two groups that were unsuccessful in front of the Seventh Circuit, Grace Schools and Biola University, and Diocese Of Fort Wayne-South Bend, Inc., filed a petition for writ of certiorari as well. These cases were also decided in favor of the government. On September 4, 2015, the Seventh Circuit issued a decision denying the request for a stay of the enforcement of the ACA’s contraception coverage requirement, holding the accommodation does not impose a substantial burden on their religious beliefs (see 7th Cir Court sticks to its guns overturns injunction for non-profit employers, Health Reform WK-EDGE, September 9, 2015). This petition filed before the Supreme Court requests a hold on the enforcement of the provision, but the Court has not yet responded.

Government

The government also filed a response brief in Zubik v. Burwell. In the brief, the government again claims that the accommodation regulations do not constitute a substantial burden which imposes on the organizations’ religious beliefs. It also states that the accommodation is the least restrictive means of furthering the government’s compelling interest in providing women with full and equal health coverage.

Justice Scalia’s absence

Now that the measure of liberals versus conservatives on the court has changed, the most likely outcome is a four-to-four tie among the justices that would leave the contraceptive mandate in place for the non-profits.